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8 posts from February 2011

February 28, 2011

Vote for HealthBlawg! Read Blawg Review #300 and then join the battle ... on my side

"Ed.," the anonymous editor of Blawg Review, has posted his 2010 Blawg Review roundup, featuring each of last year's hosts of the long-running law blog carnival, as well as a recent post from each host's blawg.  He's soliciting nominations, votes, rants, diatribes and recommendations as the battle for Blawg Review of the Year 2010 begins.  I humbly submit for your consideration Blawg Review #268, the fifth edition hosted here on HealthBlawg, themed in honor of Flag Day (which just might be related to battles, in a way). 

I took the occasion of hosting the Flag Day Blawg Review to quote our predecessor at the bar, John Adams, who once said:  "In my many years I have come to a conclusion that one useless man is a shame, two is a law firm, and three or more is a congress." 

Well, to be honest, Adams never actually said that; his character did in 1776, the musical. 

I've had the opportunity to meet Ed., in, well, OK, a bar, and in a bar he will be revealing the results of the Blawg Review of the Year 2010 showdown.  Quoth he:

We're gonna need your help to choose which of those presentations will be named Blawg Review of the Year 2010. All this week, we'll be looking for feedback. By all means, blog about it, tweet about it [be sure to cc @blawgreview], or send private emails to ed @ telling the editor who you think is most deserving of this honor. All such emails will be held in strictest confidence, if you like.

Blawg Review of the Year 2010 will be announced next Saturday, March 5th, at 7:00 pm Pacific time, live from Harry's Bar in San Francisco, where the Editor of Blawg Review and everyone who wants to attend can join us for a law blogger meetup. We will live-tweet the event, of course, and post the name of the Blawg Review of the Year 2010 as a final update to this post, as soon as it's announced.

Past winners have included Colin Samuels, Colin Samuels, Colin Samuels, Colin Samuels (OK, so he's obsessed with Dante; I get it; he eventually moved on to Coleridge, whose Rime of the Ancient Mariner was the subject of a footnote in the chapter of Moby-Dick I read last night -- really can't escape him) and Kevin Thompson.  (Kevin moved from the classics to a Hitchhiker's Guide to the Galaxy themed "Towel Day" Blawg Review; my towel's in there, somewhere.  "So long, and thanks for all the fish!"  Reminds me of the albatross, Coleridge's Rime, and Colin Samuels again.  Hmph.)

So check out the nominees, and let Ed. know what you really think of HealthBlawg, despite its recent dearth of allusions to the epic poem and humor/science fiction genres of literature.  The HealthBlawger has other qualities, no?

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

February 24, 2011

Mass General and HIPAA, or The medical records that never returned


OCR announced today that Massachusetts General Hospital settled a HIPAA violation claim, without admitting liability, for $1 million and an agreement to revamp procedures for taking patient records off premises.  The case involved a stack of paper records left on the T (Boston's subway) consisting of protected health information for a couple hundred patients, including patients on the HIV service.  (As an aside, HIV records are subject to super-deluxe Rube Goldberg-esque privacy protections in Massachusetts -- they need to be flagged so that patients can sign an additional release before they are shared, since even the fact of testing is private, though in my humble opinion the flagging vitiates some of the privacy we want to afford these records).

For those of you keeping score at home, $1 million seems serious, but not Very Serious, like yesterday's news of the $4.3 million civil monetary penalty assessed by OCR against Cignet Health in Maryland.

As I wrote yesterday, the Cignet CMP is more important as a warning to the community of covered entities that they had better take obligations under HIPAA seriously than as an action against Cignet, which appears to be spectacularly unresponsive to this and other government actions; it seems unlikely that the federales will ever collect the full $4.3 million.  The world is now on notice that OCR is not afraid to pull the trigger on $1.5 million CMP per willful violation.

The MGH settlement, however, seems to me to be more important than the Cignet case.

MGH, home of the Ether Dome and all that, has agreed, in a Resolution Agreement and Corrective Action Plan that it will develop, and submit to OCR for review and approval, policies and procedures governing physical removal and transport of PHI, and laptop and USB drive encryption, that would have addressed the incident on the T.  Policies and procedures must be distributed to the MGH workforce, training conducted for current and new employees, and any violation and remediation must be reported.  In the time-honored tradition of fighting the last war, special attention is paid to the removal of PHI from the premises.  No member of the workforce may remove PHI from the MGH premises other than for MGH work purposes, and not unless MGH certifies that he or she has received the requisite training on these policies and procedures, and reasonable and appropriate measures are taken to maintain the privacy of PHI taken off site.  MGH's internal audit department will function as the monitor for this plan, subject to OCR review and approval of a monitoring plan (which is to provide for interviews of workforce members and surprise inspections) and regular reports.

It is fascinating to me -- and possibly a wake-up call to folks concerned about loss of privacy due to digitization of health records -- that in this digital age, an age of lost laptops and stolen hard drives, an institution at the heart of Boston's identity as a medical Mecca is tripped up by carelessness with paper records.  Mass General paid $1 million to settle accounts with OCR -- a far cry from the nickel Charlie needed to get off the MTA.  It seems to me that both MGH and the rest of us ought to have learned to take better care of PHI by now.  Perhaps this case will move folks a little further in the right direction.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting


David Harlow interviewed on Social Media for Health Care

Last month, Elissa Weitzman and others, researchers at the Children's Hospital Boston informatics program, published a paper in the Journal of the American Medical Informatics Association entitled "Social but safe? Quality and safety of diabetes-related online social networks," finding that only half of the ten communities they surveyed presented content consistent with diabetes science and clinical practice.  The study found that the quality of clinical information, as well as privacy policies, varied significantly across these sites, and that some of the sites were wanting in terms of scientific accuracy, safeguards such as personal health information privacy protection, effective internal and external review processes, and appropriate advertising.  (See InformationWeek for more.) 

It seems to me that the researchers at Children's may be holding diabetes social networks to the wrong set of standards.  All participants in these communities openly share information of the sort that is otherwise kept private, and many folks use these sites in order to learn about anecdotal evidence -- often of just one case -- where an individual patient has experienced positive results from a therapy that has not been proven through a double-blind study.

Albert Maruggi interviewed me about this study, the regulatory landscape for health care social media, and best practices for "ailment communities."  You may listen to the interview and read Albert's accompanying piece at Social Media for Health Care.

Update 2/28/2011:  See the latest from Susannah Fox at the Pew Internet and American Life Project on patient preferences for dealing with health professionals vs. family, freinds and fellow patients.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

February 23, 2011

HIPAA CMPs: What's the point?

Yesterday, the federales announced: HHS Imposes a $4.3 Million Civil Money Penalty for Violations of the HIPAA Privacy Rule.  The OCR Notice of Final Determination was issued to Cignet Health of Maryland, a health plan that had not responded to members' requests for records, had not responded to OCR's requests for records once compaints had been filed with OCR, had not responded to a subpoena, and did not even bother to defend itself in federal court when OCR filed for a court order to enforce the subpoena.  I've written about the rule that allows HHS to go for fines of up to $1.5 million per offense where the covered entity's noncompliance is willful.  This is the first example of that rule being tested to the max.

OK.  We get it.  The government is Very Serious about HIPAA and HITECH.  And We Should Be Too.

Now, some of you may wonder: What is Cignet Health and why would it not even respond to all of these requests, subpoenas and federal complaints? 

Well, I wondered the same thing, and did a little digging.

Cignet Health, it turns out, has been offering health insurance (inexpensive health insurance, I might add) despite the fact that it is not licensed to do so by the State of Maryland.  It also offers health insurance overseas in the UK, in Ghana, and -- I kid you not -- Nigeria.  I have not looked into the overseas licenses.  Affiliates also include a medical group and a medical software company. 

The Maryland Insurance Commissioner issued a cease and desist order to Cignet to stop selling insurance without a license (after a complaint was filed about Cignet not paying claims), Cignet did not respond, and a default judgment was entered in the administrative matter against the company.  The final order against Cignet in the state insurance commissioner's matter was issued on October 25, 2010, just days after the OCR issued its Notice of Proposed Determination.  (The only individual named in the Maryland case had his license to practice medicine revoked in 2000 after being convicted in Federal court in New York in 1994 after trial on a 40-count indictment on mail and wire fraud charges in connection with a student loan scheme.  OCR addressed its letters to him, including an "M.D." after his name.)

The complaints and investigations being carried out at the state and federal levels were approximately concurrent.  While the details of the violations at the state and federal levels were different, at bottom this seems to be about an organization seeking to capitalize on a market opportunity without maintaining the level of compliance needed to function in a heavily regulated industry.  Either action may put the organization out of business, and the question arises: Do we want, or need, overlapping state and federal jurisdiction over matters such as these?  President Obama joked about the overlap in jurisdiction of federal agencies in his State of the Union address, and pledged to eliminate at least some of the overlap in Washington.  I'd be interested to hear about cases in which state attorneys general pursue HIPAA violations that the federales do not.  So far, I've heard only about cases pursued at both the state and federal levels, starting with the first one, the HIPAA HITECH case pursued by Connecticut AG Blumenthal, and the orders at the state and federal levels don't seem to require different actions by the subjects of the sanctions in terms of doing right by the individuals harmed.

In cases such as Cignet, it may be appropriate to have multiple attacks on wrongdoers -- though it seems unlikely that the federales will ever collect the $4.3 million this time around.   So is this really a watershed moment for HIPAA HITECH enforcement, or a case of too little, too late?

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

February 17, 2011

Massachusetts Health Reform, Part III

Today, Massachusetts Governor Deval Patrick filed health care reform legislation that, if enacted, will take the Commonwealth to the next level, taking the third step in the process that began in 2006 with the universal coverage law, and continued in 2008 with the legislation directed at containing cost and improving quality.  One of the provisions of the 2008 law established

a special commission on the health care payment system that shall investigate reforming and restructuring the system to provide incentives for efficient and effective patient-centered care and to reduce variations in the quality and cost of care.

The 2009 report of the special commission on the health care payment system was followed in 2010 by a report by the Office of the Attorney General and legislative hearings that focused on cost increases divorced from quality improvement.  Also in 2010, the Governor was engaged in close combat with health insurers over rate increases.

2011 has brought a legislative proposal designed to implement recommendations of the special commission.  The Commonwealth's blog says:  

  • The bill encourages the market to move away from the current model of health care - which pays for quantity of care, not quality – toward a system that integrates care and rewards healthier outcomes.
  • It achieves this goal in large part by encouraging the growth of integrated care organizations that support innovation and brings down costs by promoting health, not just dealing with chronic emergencies.

It also links to resources including the full text of the legislation -- An Act Improving the Quality of Health Care and Controlling Costs by Reforming Health Systems and Payments -- and a section-by-section summary.

So can you guess what the Governor has proposed?

That's right -- ACOs for all.

His filing letter says:

The bill I am filing will lower health care costs for consumers while providing the health care industry both the incentives and the freedom to innovate and find lower cost ways to deliver better care. 

This legislation will realize these goals by:

  • Giving the Commissioner of the Division of Insurance authority to consider several new criteria when deciding whether or not to disapprove excessive health insurance premium increases; 
  • Encouraging the formation and use of integrated care organizations, comprised of groups of providers that work together to achieve improved health outcomes for patients at lower costs;
  • Establishing benchmarks and timelines for the transition to “alternatives to fee for service” and the predominant use of integrated care organizations by 2015; 
  • Encouraging the use of payment methods (such as global payments, bundled payments, etc.) that will decrease total per capita expenditures on health care, and the rate of growth in expenditures for health care in the Commonwealth, and improve the efficiency, effectiveness and quality of health care delivery; 
  • Ensuring transparency and accuracy of payer and provider costs, provider payments, clinical outcomes, quality measures, and other information which is necessary to discern the value of health services; 
  • Empowering the relevant state entities to monitor and address disparities in the health care market that contribute to high health care costs; and
  • Discouraging the practice of defensive medicine and improving the quality of health care by requiring open communication between providers and patients during a “cooling off period” before litigation can commence and limiting the use of a physician’s apology in litigation.

Well, OK, he said ICOs ("integrated care organizations"), not ACOs, but you get the idea.

I have read much commentary lately suggesting that the ACO is not the holy grail of health reform, as its adoption as a model for health care finance can only result in the concentration of market power in hospital-led organizations employing more and more physicians (though never enough PCPs to deliver all the much-vaunted primary and preventive care), resulting in upward pressure on pricing, and the financial incentives that will lead to limiting of care by providers in service to the almighty dollar.

Providers have their concerns as well.  Consider Massachusetts Hospital Association Executive Director Lynn Nicholas' concerns expressed nearly eighteen months ago:

The hospital association wants legislators to include health care providers on the oversight board; shield providers from financial risks they can’t control and don’t have reserves to cover, such as a swine flu outbreak; change insurance plans so that patients are encouraged to stay within their accountable care organizations for all of their medical needs; provide extra compensation for providers who treat low-income patients and for teaching hospitals that have extra costs associated with training residents, research, and 24-hour trauma services; and offer incentives for providers to jump in and test the global payment system.

Not all of these concerns have been addressed in the Governor's bill.  I was happy to see the medical apology section, though (the bill would make medical apologies inadmissible in malpractice cases).

As always, the devil is in the details.  Most of the naysayers do not have alternative proposals.  I believe that it is important to move forward in this direction, simply because the status quo is completely untenable.  Patrick is to be commended for keeping many key players at the table for several years now (hospitals, physicians, insurance companies, business).  As I've observed before, ideals and interests help keep folks focused on making health reform work in Massachusetts. We shall see how Patrick continues to keep this unholy alliance together as this bill moves through the legislative process.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting


February 14, 2011

AQC to ACO: As goes Massachusetts, so goes the nation?

About four years ago here in Beantown, survivors of the last big ill-conceived or poorly-executed (depends who you ask) wave of health care management and finance innovation were kicking around for a new approach to aligning payor and provider incentives, focusing on quality and cost containment. To hear Andrew Dreyfus, CEO of Blue Cross Blue Shield of Massachusetts, tell the story, the Blues wanted to address both quality and cost, and therefore (after looking in vain for a model elsewhere that could be transplanted to Massachusetts) developed the Alternative Quality Contract, or AQC, which features a global payment model hybridized with substantial performance incentives, plus design features intended to lower the cost of care over time.

Many of the features put in place under the AQC will allow participating provider networks in Massachusetts to make the leap to ACO (once the beast is defined by the federales), despite the difference in payment methodology (global cap for AQC vs. FFS for ACO).

I was invited to hear Andrew present the AQC story this week together with Gene Lindsey, CEO of Atrius Health, a Massachusetts multispecialty physician network of some 700 physicians that participates in the AQC.  (Atrius'  largest group is Harvard Vanguard Medical Associates, whose docs used to be employed by Harvard Community Health Plan, the pioneering staff model HMO 'round these parts.) 

After mulling over Jeff Goldsmith's "Plan B" for ACOs in the commercial sector a few weeks back -- he thinks they need a radical redesign to work well -- it was fascinating to hear from a payor and a provider who have been working together for a few years now in what is effectively a physician-led ACO.  (Keep in mind that the vast majority of discussions about ACOs are focused on hospital-led models, with the exceptions of those by Vince Kuraitis and the HealthBlawger; please feel free to point us to others in the comments.)   An important data point in Gene's presentation is the breakdown of the budget: outpatient costs exceeded inpatient costs.  In addition to that point, the fact of the matter is that the most expensive piece of medical technology remains the physician's pen.  It therefore makes sense to place physician organizations at the center of ACOs; they don't provide all care to all members, but they do coordinate all care.

Andrew and Gene offer glowing reports from the front. More of the details are in their presentations, embedded below.


Almost half of the BCBSMA HMO members have a PCP who is enrolled in the AQC program. (They have other insurance products in the market, too, but the AQC is limited to providers that participate in the HMO plan.)  The program may be distinguished from capitation in the bad old days by three key features:

  • The first year's global payment equals the prior year's payment experience for the population served.
  • Quality measures are in place to guard against undertreatment
  • Global payments are risk-adjusted to account for the health status of individual patients

The results to date have been encouraging. There is improvement in both process and outcome measures for the populations served by providers operating under the AQC, BCBSMA is on track to reducing annual growth in costs by 1/2 within five years and provider groups participating in the AQC are seeing surpluses as a result of their integrated approach to care management.

As is the case everywhere, 50% of costs are incurred for the sickest 5% of the population, so intensive management of those cases will yield the biggest bang for the buck.  This is not news, yet effective care management seems to be.  Witness the recent Atul Gawande piece on "hot spotters" focusing on high-cost chronic care in Camden, NJ.   

For Gene Linsdey, long-time physician at Harvard Vanguard Medical Associates and its predecessor, Harvard Community Health Plan, and now CEO of Atrius Health, what rings true is guidance from the founder of HCHP, Dr. Robert Ebert:

The existing deficiencies in health care cannot be corrected simply by supplying more personnel, more facilities and more money. These problems can only be solved by organizing the personnel, facilities and financing into a conceptual framework and operating system that will provide optimally for the health needs of the population.

Ebert said this in 1969, decades before the rise of IHI and the Triple Aim ... though of course Don Berwick must've picked up some of these ideas when he was a practicing pediatrician at HCHP.  As Lindsey demonstrated, HCHP and its progeny have been tinkering with the conceptual framework and the operating system ever since.

In order for this model to work beyond the slightly unreal laboratory of BCBSMA and Atrius, where there are many long-term physician-patient relationships (so lack of a required patient buy-in to the AQC or ACO model is not that big a deal), and there are significant numbers of covered lives, a shift in thinking is required, an adoption of the patient-centered medical home mindset, and (per Lindsey) a dedication, at a large enough scale to manage the risk involved, to promote the necessary investments in organizational culture, medical management, data reporting analysis, health information and patient engagement.

As the multitude of federal agencies potentially involved in ACO regulation work out their internal differences (the FTC-DOJ catfight over who gets to write and enforce the antitrust rules that will govern ACOs is just the latest one; Stark, Anti-kickback, IRS and other rules are implicated as well), and as the elimination of overlapping agency jurisdiction -- as promised in the State of the Union address a few weeks ago -- plays out, we may well be grappling with a seismic shift in the way health care services are organized and delivered.  Here's hoping that the shift is less about jockeying for market power, and more about delivering greater value and quality to individuals in a manner that helps achieve the Triple Aim of improved population health, improved experience of care and reduced per capita cost.  

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

February 13, 2011

Pan Mass Challenge 2011: The Training and Fundraising Begin

Pmc_logo11_3c While things are still mighty cold and snowbound here in New England, and it's difficult to think about bicycling in this weather, I signed up a couple of weeks ago to ride in my eighth Pan Mass Challenge.  (It will be my second on a recumbent bike.)  For those of you not familiar with the PMC, it's the granddaddy of all athletic fundraisers, and last year alone raised over $30 million for the Dana Farber Cancer Institute's Jimmy Fund.  Thanks to the ride's sponsors, every penny of every donation goes directly to the Dana Farber.  Over 5000 riders get out on the road for the first weekend in August, and ride a variety of routes and distances, supported by many, many others, who are out cheering us on by the side of the road, are volunteering at the water stops, and who open their hearts and checkbooks.  I'll be riding the original route - Sturbridge to Provincetown, about 200 miles over two days - over the first weekend in August.

I invite you to join me in the fight to lick cancer. 

Please check out my Pan Mass Challenge profile, where you can read about my reasons for riding and some of my experiences on past years' rides (there are links from my profile page to photos and tweets from the road, too), and you can donate to the cause with just a few clicks.  I also invite you to join my PMC Facebook group so you can follow along virtually as I train for the ride (it'll get more interesting as the weather improves) and you can see some (ahem) interesting photos of me and my biking buddies.

Thanks for your support.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting

February 09, 2011

Measuring Patient Experience of Care

There is a growing recognition within the medical-industrial complex that the patient is a key element of the enterprise, and that patient satisfaction, patient experience, patient engagement, patient activation, patient-centeredness are very important.  Some research shows that patient activation yields better patient outcomes, and that patient activation can be measured.

Patient-centeredness and patient engagement are two of the key metrics to be used by the feds in describing Accountable Care Organizations (ACOs), if the internecine battles within government are resolved soon enough to actually release draft ACO regulations in time to allow for sufficient advance planning for the January 2012 go-live date.  (Wearing one of my many hats, I've had the opportunity to submit a response to CMS regarding the RFI on these metrics on behalf of the Society for Participatory Medicine.)  These measures go into the Meaningful Use hopper as well, as Meaningful Use Stage 2 metrics are being reviewed.  

In recent years, the federales have been measuring patient experience using the CAHPS surveys, and -- coming soon to a bank account near you -- there will be Medicare dollars tied to the scores on these questionnaires, not just dollars tied to the act of reporting scores.

As this emphasis on patient experience is unfolding, the Leapfrog Group is adding its voice to the chorus.  I spoke this week with CEO Leah Binder (link will take you to a HealthBlawg podcast interview with her from the archives) and Hospital Survey Director Matt Austin about the new patient experience measures they are adding to their 2011 hospital survey.  In keeping with past practice, they will be asking hospitals to report three CAHPS measures (rather than asking folks to collect and report new measures).  The three were selected as being representative of a hospital's broader performance with respect to patient experience, and also because hospital performance on these measures is all over the map.  (If everyone excels on a given measure, you can't really use it to differentiate among providers; consider what happens to hospitals participating in projects like the Premier/CMS demos: Over time, more and more observed (and incentivized) behavior creeps towards the top quintile.  That's a good thing, but you can't keep rewarding folks for hanging out in the top rank.  If everyone is above average, as the children are in Lake Wobegone, nobody deserves props; it's time to focus on improving another metric.)

The three measures are:

  • Pain Management: "Patients who reported that their pain was 'Always' well controlled."
  • Communication about Medicines: "Patients who reported that staff 'Always' explained about medicines before giving it to them."
  • Discharge Information: "Patients at each hospital who reported that YES, they were given information about what to do during their recovery at home."

Once the survey data is reported in by hospitals (April-June) the Leapfrog Group will score hospitals' performance, but only aggregate scores on these new measures will be reported publicly in year 1.  (Hospital-specific data on these measures will be reported back only to the hospital reporting the data.)

This seems to me to be a reasonable step forward.  In an era when many health care providers are focused on improving patient experience by providing WiFi service in waiting areas and hiring managers from the hotel industry, it is important to focus on core areas of hospital performance.  The question remains: is the CAHPS survey the best way of getting a valid assessment of this performance?   The next step may be to pilot a survey that queries patients at random times during a hospitalization via cell phone about measures like pain management.  The theory is that on-the-spot assessments are likely to be more accurate than CAHPS survey responses provided after the fact.

By continuing to identify measures that prove to be valid differentiators among hospitals, the Leapfrog Group continues to provide a valuable service to its members.

David Harlow
The Harlow Group LLC
Health Care Law and Consulting